Registration Dossier
Registration Dossier
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EC number: 947-930-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-22 to 2003-05-25
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tris(2-ethylhexyl) 2-hydroxypropane-1,2,3-tricarboxylate
- EC Number:
- 230-457-3
- EC Name:
- Tris(2-ethylhexyl) 2-hydroxypropane-1,2,3-tricarboxylate
- Cas Number:
- 7147-34-4
- Molecular formula:
- C30H56O7
- Test material form:
- other: colourless liquid
- Details on test material:
- Bernel Ester TCC (Tricapryl Citrate), Lot #P1585
Colourless lliquid stored at room temperature
100%. Test substance was expected to be stable for the duration of testing
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- New Zealand Albino, one male 2 female young adults. They were housed singly. Temperature 20-22 C with 12/12 hour light/dark cycle.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL to 6cm2 per animal
- Duration of treatment / exposure:
- After 4 hours the pads and collars were removed and the test sites cleansed of any residue substance
- Observation period:
- 1, 24, 48 and 72 hours after removal of patch
- Number of animals:
- 3
- Details on study design:
- Individual dose sites were scored according to the Draize scoring system. The classification of irritancy was obtained by adding the average erythema and edema scores for the 1, 24, 48 and 72-hour scoring intervals and dividing by the number of evaluation intervals (4). The resulting Primary Dermal Irritation Index (PDII) was classified as follows:
0 - Non-irritiating
>0-2.0 - Slightly irritating
2.1-5.0 - Moderately irritating
>5.0 - Severely irritating
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Primary Dermal Irritation Index
- Conclusions:
- Under the conditions of this study, the test substance is classified as slightly irrritating to the skin.
- Executive summary:
3 New Zealand Albino rabbits had 0.5mL of the test substance topically applied to a clipped 6cm2 area of skin which was then covered semi-occlusively for 4 hours. No edema was noted for any treated site during the study.
At one and 24 hours after the patch removal slight erythema was evident at all 3 treated sites in all animals. All animals were free from dermal irritation at 48 hours. The Primary Dermal Irritation Index was 0.5. Under the conditions of this study, the test substance is classified as slightly irrritating to the skin.
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